Exact power and sample size in clinical trials with two co-primary binary endpoints.
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DOI: 10.1177/09622802251368697
Abstract: Binary endpoints are used widely to evaluate treatment effects during clinical trials. Although clinical trials in many therapeutic areas evaluate a single binary endpoint as the primary endpoint, clinical trials in certain therapeutic areas require… read more here.
Keywords: sample size; two primary; binary endpoints; clinical trials ... See more keywords
Extension of a conditional performance score for sample size recalculation rules to the setting of binary endpoints
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DOI: 10.1186/s12874-024-02150-4
Abstract: Background Sample size calculation is a central aspect in planning of clinical trials. The sample size is calculated based on parameter assumptions, like the treatment effect and the endpoint’s variance. A fundamental problem of this… read more here.
Keywords: sample size; score; binary endpoints; performance score ... See more keywords
Optimal futility stopping boundaries for binary endpoints
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DOI: 10.1186/s12874-024-02190-w
Abstract: Background Group sequential designs incorporating the option to stop for futility at the time point of an interim analysis can save time and resources. Thereby, the choice of the futility boundary importantly impacts the design’s… read more here.
Keywords: probability; time; futility; optimal futility ... See more keywords